Trial | NCT04501380  Report issue

Title

Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
A Randomized Open Label Trial Evaluating the Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Enrolling by invitation

  • Study Participants

    30
Open label interventional randomized pilot study utilizing two dosing regimens of AEMCOLO. The goal of this study is to evaluate effectiveness of a novel antibiotic, AEMCOLO (Rifamycin SV MMX) in the treatment of Small intestinal bacterial overgrowth (SIBO).
Study Started
Jun 30
2020
Primary Completion
Dec 30
2022
Anticipated
Study Completion
Dec 30
2022
Anticipated
Last Update
May 05
2022

Drug AEMCOLO (Rifamycin SV MMX)

Participants will be issued a patient kit containing AEMCOLO (Rifamycin SV MMX) 194 mg tablets for the 1st or the 2nd treatment regimen in a random order.

1st regimen Experimental

15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)

2nd regimen Experimental

15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).

Criteria 

Inclusion Criteria:

Symptoms compatible with SIBO
A positive breath test for either hydrogen predominant, methane predominant or mixed SIBO

Exclusion Criteria:

History of diabetes mellitus,
Diarrhea predominant irritable bowel syndrome (IBS-D),
Symptomatic bowel obstruction,
Diverticulitis and/ or adhesions,
Autoimmune disorder,
Immunosuppression by medication or disease,
Pregnant or breast feeding,
The use of antibiotics, probiotics or prebiotics within the previous 30 days,
Known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components of AEMCOLO.
No Results Posted